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Trial registered on ANZCTR


Registration number
ACTRN12618001894280
Ethics application status
Approved
Date submitted
16/11/2018
Date registered
21/11/2018
Date last updated
8/01/2019
Date data sharing statement initially provided
21/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive Behaviour Therapy (CBT) and Mindfulness for Endometriosis.
Scientific title
A Pilot Study Investigating Cognitive Behavioural Therapy (CBT) and Mindfulness for Endometriosis: Does presentation style influence outcomes?
Secondary ID [1] 296498 0
Nil Known.
Universal Trial Number (UTN)
U1111-1224-0837
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 310445 0
Persistent Pain 310448 0
Condition category
Condition code
Mental Health 309166 309166 0 0
Studies of normal psychology, cognitive function and behaviour
Renal and Urogenital 309200 309200 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A Pilot Study Investigating Cognitive Behavioural Therapy (CBT) and Mindfulness Interventions for Endometriosis. There are two phases of the pilot study: Treatment Component and Research Component.

There will be three participation levels (Group, Self-Instruction, Care as Usual) and participation will be determined in conjunction with the participant. The Group Intervention will occur in private practice locations within the Hobart CBD. The Focus Groups will occur at the University of Tasmania, College of Health and Medicine, School of Medicine (Division of Psychology), Sandy Bay campus. Activities completed by women engaged in the Self-Instruction or Care As Usual group will occur within a setting of the participant's choice (e.g., home).

Phase 1: Treatment Component: Women who indicate a willingness to engage in the intervention will complete a brief screening interview with a registered Psychologist that will assess inclusion and exclusion criteria and suitability for psychological intervention. Women who meet the inclusion criteria for participation will be offered a choice of intervention level (Open Label Allocation). There is no out of pocket expense or gap fee payable for any participant regardless of intervention level (Group, Self-Instruction, Care as Usual). All participants will complete the pre-intervention, intervention interval, post intervention and six-month follow up assessments via Redcap, an online survey portal.

The Group intervention will consist of 8 x 2 hour weekly CBT and mindfulness intervention sessions and 1 x 2 hour follow up session. The self-instruction group will receive the same 8 modules to be completed on a weekly basis. The Care as Usual group will not receive the treatment information but will complete the same weekly outcome measures, via an online portal, as the two intervention groups.

The material covered in the CBT and mindfulness intervention will focus on perception and acceptance of a diagnosis of endometriosis with special attention paid to the experience of pain and loss of personal, relational, sexual and occupational functioning. Interventions will aim to improve health-related quality of life and to decrease psychological distress. Intervention areas have been chosen based on their pertinence for inclusion in therapy based on the known symptoms associated with endometriosis including activity and fatigue; anxiety/stress; depression; relationships; vocational/occupational/social engagement; pain management; acceptance and mindfulness. Specific skills that will be addressed in the interventions include, but are not limited to, relaxation skills training, behavioural activation and experiments, cognitive restructuring, goal setting, pacing, habit reversal, stimulus control and assertive communication. The written and audio material used for the intervention will be designed specifically for the study. The intervention will be compiled and delivered by a registered Psychologist with extensive experience in CBT and Mindfulness interventions, Women's Health and Persistent Pain (10 years minimum experience).

Intervention adherence will be monitored via completion of online assessment of the weekly content in the form of knowledge content and skills acquisition. Participants will also have an opportunity to provide written feedback regarding their use of materials presented in each module on a weekly basis. Participants who do not attend a scheduled session will be contacted via telephone to discuss nonattendance. Participants in the self-instruction or Care as Usual component will be contacted via telephone if they do not complete one of the scheduled assessments.

Phase 2: Research Component: Women engaged in the treatment component will be provided with an opportunity to share their de-identified treatment outcome data with the researchers. They may also choose to take part in focus group discussions (group or individual) regarding their perception of the intervention. The research component will be conducted via the University of Tasmania, College of Health and Medicine, School of Medicine (Division of Psychology). The focus groups will occur two weeks following completion of the intervention and two weeks following the follow-up session. Women can choose to attend these face to face or provide written responses to the focus group questions.
Intervention code [1] 312937 0
Treatment: Other
Intervention code [2] 312938 0
Lifestyle
Intervention code [3] 312939 0
Behaviour
Comparator / control treatment
Women waiting to engage in the group or self-instruction intervention will be categorised as a Care as Usual group and complete the same pilot study assessment battery as those receiving intervention. Women in the Care as Usual group do not receive any intervention materials and continue to engage in the same treatment pathways as they were engaged in prior to commencing the 8-week care as usual time period. Information will be gathered regarding any change to their treatment during the 8-week period (e.g., medication changes, therapy engagement, surgery).
Control group
Active

Outcomes
Primary outcome [1] 308139 0
Quality of Life:

Endometriosis Health Profile (EHP-30): This is a health- related quality-of-life (HRQoL) questionnaire developed to specifically address the impact of the disease on the physical, psychological, and social aspects of women’s lives.
Timepoint [1] 308139 0
Baseline (7 days prior to completing week one), Posttreatment (within 7 days of completion of the final intervention session) and at six-month follow-up.
Secondary outcome [1] 354070 0
Psychological Health:

The Depression, Anxiety, Stress Scale – 21 (DASS-21; Lovibond & Lovibond, 1995) is designed to measure presence of symptoms associated with depression, anxiety and stress.
Timepoint [1] 354070 0
Baseline (7 days prior to completing week one), weekly treatment interval (week 1-8), Posttreatment (within 7 days of completion of the final intervention session) and six-month follow-up.
Secondary outcome [2] 354071 0
Pain Measure 1:

Visual Analogue Scales will be used to record pain ratings during the intervention.
Timepoint [2] 354071 0
VAS: Baseline (7 days prior to completing week one), weekly treatment interval (week 1-8), Posttreatment (within 7 days of completion of the final intervention session) and six-month follow-up.
Secondary outcome [3] 354072 0
Mindfulness:

The Cognitive and Mindfulness Scale, revised (CAMS-R) was designed to measure mindfulness with the intention that it would be a generic measure appropriate regardless of meditation experience.
Timepoint [3] 354072 0
Baseline (7 days prior to completing week one), weekly treatment interval (week 1-8), Posttreatment (within 7 days of completion of the final intervention session) and six-month follow-up
Secondary outcome [4] 354153 0
Pain Measure 2:

The West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) is designed to provide a brief, psychometrically-sound, and comprehensive assessment of the important components of persistent pain and is focused on the cognitive behavioural aspects of the pain experience. It measures perceived interference of pain, support or concern from spouse or significant others, pain severity, perceived life control, and affective distress.

Timepoint [4] 354153 0
(WHYMPI/MPI): Baseline (7 days prior to completing week one), Posttreatment (within 7 days of completion of the final intervention session) and six-month follow-up.
Secondary outcome [5] 354155 0
Pain Measure 3:

The Coping Strategies Questionnaire (CSQ-24) will be used to measure cognitive and behavioural pain coping strategies.
Timepoint [5] 354155 0
CSQ-24: Baseline (7 days prior to completing week one), Posttreatment (within 7 days of completion of the final intervention session) and six-month follow-up.

Eligibility
Key inclusion criteria
Participants will be women, aged 18 years or over, who experience symptoms of endometriosis. Inclusion criteria for all women will include information regarding diagnostic classification (e.g., diagnostic category, disease stage/classification) and a referral letter completed by their general practitioner for treatment participation.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for all women will be current engagement in group psychological treatment, current experience of psychosis, substance abuse, mania, or suicidal ideation and intent. Women with significant cognitive deficits will also be excluded due to the ethical requirements of informed consent and a potential inability to self-select and due to the cognitive nature of the specific interventions. Pregnant women will be excluded to minimise the possibility of an inability to complete the program due to pregnancy-related factors. However, due to ethical and professional duty of care, women who conceive while completing the program will be able to continue.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Data will be analysed to assess changes in mean scores at baseline, treatment interval, post-treatment and follow-up. Specifically, reliable clinical change index (Jacobson & Truax, 1991) will be used. Participants in the two intervention delivery modes will be matched using matched pairs. It is expected pairing will be based on age, educational and professional status, socio-demographic status, parity and stage of disease. Baseline, Treatment Interval, Posttreatment assessments and a Six-Month follow-up will allow for review of treatment efficacy and maintenance. Women waiting to engage in the Group or Self-Instruction intervention will be categorised as a Care as Usual group and complete the same pilot study assessment battery as those receiving intervention.

Data will be analysed to assess clinically significant and reliable changes in mean scores at baseline, treatment interval, post-treatment and follow-up. Potential bias has been accounted for by blinding between the Treatment and Research Components, participant sample (community), and independent facilitator adherence measures. Confounding factors will be accounted for by gathering disease-specific diagnosis, severity and treatment information.

It is anticipated that mixed models with repeated measures will be used. The dependent variable will be the EHP-30 Total. Fixed Independent variables will include Group (Intervention Level: Group, Self-Instruction, Care as Usual) and Time (Preassessment, Treatment Interval, Postassessment, Follow-up). Participant variables (e.g., disease stage, socioeconomic status) will be controlled for.

Reliable Change Index (Jacobson, Follette, & Revenstorf, 1984) will be used to analyse the data. RCI measures whether the change in measured outcomes pre and post intervention is statistically significant and unlikely to be due to simple measurement unreliability. The following formula will be used: SD1*sqrt(2)*sqrt(1-rel), where SD1 is the initial standard deviation, sqrt indicates the square root and rel indicates the reliability. For this study, test-retest reliability of the measures used will be used in the formula.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 301086 0
University
Name [1] 301086 0
University of Tasmania
Address [1] 301086 0
University of Tasmania
College of Health and Medicine
School of Medicine (Division of Psychology)
Private Bag 30
HOBART TAS 7001
Country [1] 301086 0
Australia
Funding source category [2] 301207 0
Charities/Societies/Foundations
Name [2] 301207 0
Australian Psychological Society Clinical College Research Grant
Address [2] 301207 0
PO Box 38
Flinders Lane VIC 8009
Country [2] 301207 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
University of Tasmania
College of Health and Medicine
School of Medicine (Division of Psychology)
Private Bag 30
HOBART TAS 7001
Country
Australia
Secondary sponsor category [1] 300839 0
None
Name [1] 300839 0
Address [1] 300839 0
Country [1] 300839 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301836 0
Tasmanian Health and Medical Human Research Ethics Committee
Ethics committee address [1] 301836 0
Office of Research Services, University of Tasmania, Private Bag 1, Hobart, TAS, 7001
Ethics committee country [1] 301836 0
Australia
Date submitted for ethics approval [1] 301836 0
20/08/2018
Approval date [1] 301836 0
22/10/2018
Ethics approval number [1] 301836 0
H0017592

Summary
Brief summary
The current pilot study study aims to: 1) examine the effectiveness of an 8-session, 2-hour group, CBT and mindfulness intervention in reducing psychological distress and improving quality of life, 2) compare the efficacy of intervention delivery method (group versus self-instruction) and 3) produce a CBT and mindfulness treatment protocol that is evidence-based and cost-effective for both practitioners and clients. Women aged 18 years or over, who experience symptoms of endometriosis, will choose to participate in one of three groups: Group, Self-Instruction or Care as Usual (Open Label design).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88274 0
Dr Leesa Van Niekerk
Address 88274 0
University of Tasmania
College of Health and Medicine
School of Medicine (Division of Psychology)
Private Bag 30
Hobart TAS 7001
Country 88274 0
Australia
Phone 88274 0
+61362266645
Fax 88274 0
Email 88274 0
Leesa.Vanniekerk@utas.edu.au
Contact person for public queries
Name 88275 0
Dr Leesa Van Niekerk
Address 88275 0
University of Tasmania
College of Health and Medicine
School of Medicine (Division of Psychology)
Private Bag 30
Hobart TAS 7001
Country 88275 0
Australia
Phone 88275 0
+61362266645
Fax 88275 0
Email 88275 0
Leesa.Vanniekerk@utas.edu.au
Contact person for scientific queries
Name 88276 0
Dr Leesa Van Niekerk
Address 88276 0
University of Tasmania
College of Health and Medicine
School of Medicine (Division of Psychology)
Private Bag 30
Hobart TAS 7001
Country 88276 0
Australia
Phone 88276 0
+61362266645
Fax 88276 0
Email 88276 0
Leesa.Vanniekerk@utas.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant consent relates to the provision of de-identified data to the researchers outlined on the participant consent form. The researchers do not have consent to share raw data for other purposes.
What supporting documents are/will be available?
No other documents available
Summary results
No Results